Medically capable of undergoing the planned surgical gross total resection and the catheter placement.

Age ≥ 18.

Karnofsky Performance Status of ≥ 70%.

Life expectancy of ≥ 3 months.

Patients must already be taking or begin taking corticosteroids at a stable dose of 4 mg every 6 hours for at least 72 hours prior to catheter placement.

Patients must be capable of taking, or already taking, anticonvulsant medication.

Patients must have read, signed, and dated an informed consent according to ICH-GCP, the local regulatory requirement and the rules followed at each institution.

Exclusion Criteria:

Patients fulfilling any of the following criteria should not be enrolled in the study:

Previous myelosuppressive chemotherapy within the past 4 weeks of the start of the infusion. Patients who have received more than two chemotherapy regimens (single therapy or combination therapy) are ineligible.

Any form of brain radiation within 10 weeks of the start of the infusion.

Midline brain shift on MRI scan of > 0.5 cm prior to resection; patients with subfalcine herniation may be enrolled.

Tumors involving the brainstem or cerebellum.

Diffuse subependymal or CSF disease.

Women who are pregnant or breast feeding. All women of child-bearing potential should be excluded unless they have a negative pregnancy test and are using adequate contraceptive measures or are surgically sterile. Post-menopausal women must be amenorrhoeic for at least 12 months to be considered of non-childbearing.

Fertile males not practicing adequate contraception and whose female partners are not using adequate contraceptive protection.

Prior or concurrent investigational treatment within 30 days of study entry.

Active infection requiring treatment or having an unexplained febrile illness.

Systemic diseases or other conditions which may be associated with unacceptable anesthetic/operative risk and/or which would not allow safe completion of this study protocol.

Prior or concurrent malignancy (curatively treated carcinoma-in-situ or basal cell carcinoma or patients who have been disease free for at least 5 years are eligible).

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.